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Association with brain size and developmental outcomes with Body composition in the moderate to late preterm infant.

Association with brain size and developmental outcomes with Body composition in the moderate to late preterm infant.

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12625001012460
Enrollment
35
Registered
2025-09-11
Start date
2023-11-01
Completion date
2027-08-01
Last updated
2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study aims to understand how body composition (the balance of fat and muscle) in babies born moderately to late preterm affects their brain development and later outcomes. We hypothesise that these babies will have more body fat and less muscle compared to babies born at full term, and that having more muscle and less fat will be associated to larger brain size and better development. To investigate this, we will measure babies’ body composition, growth, blood hormone levels, and brain size on MRI scans around their due date, and then follow their development at 4 months and 2 years of age. Comparing these findings with babies born at full term will help us see how early growth patterns influence long-term health and learning. The study hopes to identify early markers that can guide care to support healthier growth and development in preterm and growth-restricted infants.

Interventions

Participants are infants born moderate- to late-preterm (32+0–36+6 weeks) or with intrauterine growth restriction (<3rd centile or crossing greater than or equal to 2 growth centiles), compared with healthy term-born infants (39–41 weeks). The exposure of interest is preterm/IUGR birth and associated nutritional/growth factors, including, body composition IGF-1 levels. What is involved for participants; Growth and body composition assessments: weight, length, head circumference weekly until dis

Participants are infants born moderate- to late-preterm (32+0–36+6 weeks) or with intrauterine growth restriction (<3rd centile or crossing greater than or equal to 2 growth centiles), compared with healthy term-born infants (39–41 weeks). The exposure of interest is preterm/IUGR birth and associated nutritional/growth factors, including, body composition IGF-1 levels. What is involved for participants; Growth and body composition assessments: weight, length, head circumference weekly until discharge; PeaPod body composition at term age and 3 months corrected. IGF-1 serum levels via blood test: 36–72 hours after birth, then weekly until discharge, Brain MRI at term corrected age (~40 weeks), Neurodevelopmental assessments: Prechtl’s General Movements and Hammersmith Infant Neurological Examination at 3–4 months corrected, Bayley-IV developmental assessment at 2 years corrected, Blood pressure at 2 years corrected. Duration of observation; Participants are followed from birth until 2 years corrected age

Sponsors

Dr David Mc Hugh, Monash University
Lead SponsorIndividual

Eligibility

Sex/Gender
All
Age
0 to 3 Days
Healthy volunteers
Yes

Inclusion criteria

Babies born between 32+0 and 35+6 weeks’ gestation admitted to the neonatal unit or maternity ward. The control group will be healthy term infants born 39-41 weeks.

Exclusion criteria

Neonates born with congenital abnormalities or metabolic conditions that are likely to affect growth, body composition or neurodevelopmental outcomes.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026